Senior Manager Clinical Operations (m/f/d) (Referent/in - Klinische Studien (CRA))

Your Responsibilities

• Plan, organize, conduct, oversee, and evaluate national and international single-center and multicenter clinical studies in accordance with ICH-GCP, applicable regulations, and internal SOPs
• Obtain and review proposals from CROs and select, guide, and oversee CROs and other external service providers
• Conceptualize and prepare study protocols, case report forms, and final reports, and ensure the required entries in internal and external study databases
• Continuously maintain study documentation, including the Trial Master File, and select study sites and DSMB members
• Organize and conduct investigator and DSMB meetings, perform sponsor oversight activities, and support co-monitoring and oversight of study sites
• Coordinate investigational product supply and document investigational product consumption, and provide information to authorities and ethics committees
• Prepare for and participate in audits and inspections, and prepare and continuously implement required corrective and preventive actions (CAPAs)
• Take responsibility for cost planning, budgeting, and monthly study status reporting in accordance with internal requirements
• Contribute to relevant SOP updates, regulatory documents, and the presentation or publication of study results, participate in relevant congresses in coordination with the supervisor, and provide subject-matter guidance and support to colleagues

Your Qualifications

• Completed university degree in natural sciences, preferably in biology, biochemistry, pharmaceutical sciences, nutrition or a related field
• At least five years of experience as a Project Manager or Clinical Trial Manager in the GCP area
• Experience in guiding and supporting colleagues
• Proven ability to manage several projects simultaneously within approved budgets, timelines, and quality requirements
• Curiosity and openness to evolving clinical research approaches, particularly Real-World Evidence and the use of artificial intelligence
• Proven ability to work independently, understand the scientific rationale of study protocols, and coordinate internal and external project contributors
• High level of initiative, reliability, diligence, team orientation, flexibility, and resilience
• Excellent written and verbal communication skills in English and German
• Confident use of Microsoft Office and Outlook

What we offer

Bring your clinical operations expertise to an international environment and help ensure the successful delivery of high-quality clinical studies.